The Effect of Patient Position Changes on Advanced Cardiac Indices in Cancer Surgery

April 26, 2026 updated by: Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

The Impact of Patient Position Changes on Advanced Hemodynamic Indices in Laparoscopic and Open Major Abdominal Cancer Surgeries

Esophageal Doppler Monitoring (Deltex CardioQ Esophageal Doppler Monitor, ODM) is used to manage patients' fluid therapy by non-invasively measuring continuous cardiac output with an esophageal probe. The aim of this study was to compare the effects of patient position changes on cardiac indices and vital signs in patients who underwent major abdominal cancer surgery with laparoscopic and open surgery using ODM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who underwent major abdominal cancer surgery using ODM in the operating room of our hospital between November 2021 and November 2022 were identified from the Anesthesiology Clinic records and examined according to whether they were operated with open or closed (laparoscopic) methods. Demographic data, vital signs, amount of bleeding, type and amount of fluid administered, and the results of cardiac index measurements performed with the ODM device in the supine and trendelenburg positions (45 degrees) were analyzed. Parameters recorded with the ODM device; CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06200
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Train and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The patients included in the study were intubated after standard anaesthesia induction with fentanyl 2 mcg/kg, propofol 2 mg/kg and rocuronium 0.6 mg/kg, and ODM was used for case follow-up. All patients were followed with standard 6% desflurane anaesthetic gas and intravenous infusion of remifentanil, a short-acting opioid, after intubation. Mean arterial pressure was kept in the range of 65-80 mmHg in all patients, tidal volume was adjusted as 6-8 ml/kg, peep (positive end expiratory pressure) as 0-6 cm H2O and respiratory frequency as 10-15 /min for normocapnia. After intubation, intraoperative ODM measurements and intraoperative ODM measurements were retrospectively scanned and recorded in the supine and 45-degree angle trendelenburg position.

Description

Inclusion Criteria:

  • Elective operation
  • ASA 1-4

Exclusion Criteria:

  • Heart failure
  • Valvular heart disease,
  • Patients with symptomatic rhythm disturbances
  • ODM placement contraindicated (coagulopathy, oesophageal varices, known aortic aneurysm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ODM measurements of patients undergoing open surgery in supine and trendelenburg position
After intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded.
Procedure: cardiac indices in supine and trendelenburg position
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery
ODM measurements of patients undergoing laparoscopic surgery in supine and trendelenburg position
After intubation, serial ODM measurements were performed in the supine and trendelenburg position of the patient and CO: Cardiac output, FTc: Flow time corrected, PV: Peak velocity, SD: Stroke distance values were recorded.
Procedure: cardiac indices in supine and trendelenburg position
Cardiac indices in supine and trendelenburg position in patients undergoing open or laparoscopic major cancer surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac Output
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Stroke Volume
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Flow time corrected
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Peak Velocity
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Stroke Distance
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Mean arterial pressure
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case
Pulse
Time Frame: Immediately after induction of anaesthesia and at any stable time during the case
Measurement of cardiac output with the oesophageal doppler device immediately after induction of anaesthesia and in the middle of the case in both supine and trendelenburg position of the patient to see whether there is a significant difference in positional change.
Immediately after induction of anaesthesia and at any stable time during the case

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mustafa Kemal SAHIN, M.D, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-11/2097

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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